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NCT06191965 · ClinicalTrials.gov registry record · Phase 2
MitoQ for Early-phase Schizophrenia-spectrum Disorder and Mitochondrial Dysfunction
A Phase 2 study of Cognitive Impairment and Schizophrenia and Related Disorders, sponsored by Mclean Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 3
- Study locations
NCT06191965 is a Phase 2 study of Cognitive Impairment and Schizophrenia and Related Disorders that is actively recruiting participants, run by Mclean Hospital. The registered enrollment target is 100 participants, below the 665-participant average among 105 other Cognitive Impairment trials with a reported enrollment target (85% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT06191965, a Phase 2 study of Cognitive Impairment and Schizophrenia and Related Disorders, is actively recruiting participants, sponsored by Mclean Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 3
- Study locations
Study Summary
The goal of this double-blind, placebo-controlled randomized clinical trial is to test the effect of 12 weeks of orally administered MitoQ (mitoquinol mesylate) supplementation on cognition in 50 people with early phase schizophrenia-spectrum disorders (E-SSD) who have mitochondrial dysfunction (called high risk, or HR). Cognitive impairments in SSD can cause significant disability. Yet, there are no effective treatments for cognitive impairments in SSD. It has been shown that alterations in a certain type of brain cell (parvalbumin interneurons, or PVI) underlie cognitive deficits in SSD. These PVI, which fire at a fast rate, utilize high amounts of energy from the mitochondria and are highly vulnerable to oxidative stress. MitoQ is an antioxidant. Research has shown that, in mice, MitoQ can reduce oxidative stress in the mitochondria. The main question that this clinical trial aims to answer is: • Does MitoQ supplementation, compared to placebo, improve cognition in HR patients? Secondary questions that this clinical trial aims to answer are the following: Does MitoQ supplementation, compared to placebo: * Improve positive and negative symptoms of SSD in HR patients? * Improve functioning in HR patients? * Improve/normalize blood markers of mitochondrial dysfunction in HR patients? The investigators will enroll 100 individuals with E-SSD. These enrolled participants will participate in an initial screening visit to determine if they qualify for the actual clinical trial. At the screening visit, the investigators will ask about psychiatric history to determine diagnosis; ask about medical history; do a physical exam; collect blood and urine samples; do a pregnancy test; and ask participants to bring in their current medications in their original packaging so it is known what they are taking. After the screening visit, the investigators will invite 50 HR patients (identified with a blood test) to continue with the clinical trial. Participants who qualify for th
Conditions Studied
Interventions
- DRUG Placebo
- DRUG MitoQ
Study Locations (3)
Connecticut
- Yale School of Medicine - New Haven
Massachusetts
- McLean Hospital - Belmont
Other
- University of Lausanne - Lausanne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-06-01 |
| Est. Completion | 2027-01-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06191965
The ClinicalTrials.gov registry entry for NCT06191965 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 665-participant average among 105 other Cognitive Impairment trials with a reported enrollment target (85% lower). The listed sponsor is Mclean Hospital, which has 140 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Cognitive Impairment appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06191965 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Connecticut, Massachusetts, Other.
Frequently Asked Questions
What is clinical trial NCT06191965 about?
NCT06191965 is a clinical study titled "MitoQ for Early-phase Schizophrenia-spectrum Disorder and Mitochondrial Dysfunction". The goal of this double-blind, placebo-controlled randomized clinical trial is to test the effect of 12 weeks of orally administered MitoQ (mitoquinol mesylate) supplementation on cognition in 50 people with early phase schizophrenia-spectrum disorders (E-SSD) who have mitochondrial dysfunction (cal...
What is the current status of trial NCT06191965?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2024-06-01. Estimated completion is 2027-01-31.
What conditions does trial NCT06191965 study?
This clinical trial studies the following conditions: Cognitive Impairment, Schizophrenia and Related Disorders, Mitochondrial Alteration.
What interventions are being tested in trial NCT06191965?
The interventions under investigation include: Placebo (DRUG), MitoQ (DRUG).
Who is sponsoring clinical trial NCT06191965?
This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06191965 being conducted?
This trial has 3 study locations across Connecticut, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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